study of patritumab deruxtecan plus pembrolizumab with other anticancer agents in participants with high-risk early-stage triple-negative or hormone receptor-low positive/her-2 negative breast cancer (mk-1022-010, herthena-breast-03)

Conditions: Breast Neoplasms; Breast Cancer

Summary: researchers are looking for new ways to treat triple-negative breast cancer (tnbc) and hormone receptor (hr) low positive/human epidermal growth factor receptor-2 (her2) negative breast cancer. the main goals of this study are to learn: * about the safety of the study treatments and if people tolerate them * if people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has locally advanced, non-metastatic (m0), breast cancer, defined as any of the following combined primary tumor (t) and regional lymph node (n) staging per current american joint committee on cancer (ajcc) criteria: ct1c, n1-n2; ct2, n0-n2; ct3, n0-n2; or ct4a-d, n0-n2 * has centrally confirmed diagnosis of breast cancer that is triple-negative or hr-low+/her2- breast cancer that will be treated according to the triple-negative breast cancer (tnbc) paradigm * participants who are hepatitis b surface antigen (hbsag) positive are eligible if they have received hepatitis b virus (hbv) antiviral therapy for at least 4 weeks and have undetectable hbv viral load * participants with a history of hepatitis c virus (hcv) infection are eligible if hcv viral load is undetectable * has an eastern cooperative oncology group (ecog) performance status of 0 to 1 within 28 days prior to allocation/randomization * has left ventricular ejection fraction (lvef) of ≥50% or ≥ lower limit of normal (lln) as assessed by echocardiogram (echo) or multigate acquisition scan (muga) scan exclusion criteria: the main exclusion criteria include but are not limited to the following: * has uncontrolled or significant cardiovascular disease before randomization * has clinically significant corneal disease * has human immunodeficiency virus (hiv) infection with a history of kaposi sarcoma and/or multicentric castleman disease * has received prior therapy with an anti-programmed death (pd)-1, anti-pd-l1, or anti-pd-l2 agent, or with an agent directed to another stimulatory or coinhibitory t-cell receptor * has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer * has received prior treatment with an anti-human epidermal growth factor receptor 3 (her3) antibody and/or antibody-drug conjugate (adc) that consists of an exatecan derivative that is a topoisomerase i inhibitor (e.g., trastuzumab deruxtecan) * has metastatic (stage iv) breast cancer or cn3 nodal involvement * has known additional malignancy that is progressing or has required active treatment within the past 5 years * has known active central nervous system (cns) metastases and/or carcinomatous meningitis * has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ild/pneumonitis cannot be ruled out by standard diagnostic assessments * has an active infection requiring systemic therapy * has concurrent active hbv and hcv infection * has clinically severe respiratory compromise resulting from intercurrent pulmonary illness